See "TOPAZ Phase 2 Trial Interim Analysis" below. We anticipate initial clinical response and safety data in the second half of 2021. However, products utilizing conventional approaches have seen only limited success. 9679;Identify the next indication for apitegromab. Patients are ambulatory and their life expectancy is normal. In contrast, slow-twitch fibers are important for endurance activities. Both of these approaches, however, have significant limitations. Other patients' cancers appear to initially respond but subsequently progress. We are entitled to sublicense the rights granted to us under the CMCC Agreement. Collectively, there are 167 national or direct utility applications pending or issued. As described, a portion of our TGFβ technology is out-licensed to Janssen. Related product-by-process claims are included in issued U.S. Patent No. This patent family is projected to expire in November 2035. This family is projected to expire in March 2037. Thus, we may not be able to meaningfully protect our trade secrets. At this time, there are no FDA- or EMA-approved muscle-directed treatments for SMA. Payments made to physicians in certain EU Member States must be publicly disclosed. All of our employees are based in the United States and most are based in Massachusetts. We also initiated the DRAGON Phase 1 trial for SRK-181 in cancer immunotherapy. In addition, there is a natural transition period when a new CRO begins work. Designation as a breakthrough therapy is within the discretion of the FDA. We may also submit marketing applications in other countries. This final rule codified CMS's policy change that became effective January 1, 2019. We continue to evaluate what effect, if any, these rules will have on our business. In addition, we may not pursue or obtain patent protection in all relevant markets. These lawsuits may consume our time and other resources even if we are successful.